Clinical-stage company ImmusanT's therapeutic vaccine Nexvax2 has demonstrated a positive outcome in the Phase Ib trial for the treatment of coeliac disease.
Nexvax2 is an intradermally administered, epitope-specific immunotherapy (ESIT) with three immunodominant peptides designed to protect against gluten exposure.
ESIT uses short soluble peptides with dominant epitopes recognised by CD4+ T-cells, which are reportedly found in autoimmune pathologies.
The results from the trial showed that the therapeutic candidate has met its objectives during dose escalation and identified a Phase II dose regimen.
The randomised, double-blind, placebo-controlled, dose titration Phase Ib trial evaluated the safety and tolerability of gradual dose escalation before increased maintenance doses in 38 patients, who were stratified by HLA-DQ2.5 genotype.
ImmusanT president and chief executive officer Leslie Williams said: “We are very pleased with the completion of our Phase 1b clinical trial testing Nexvax2 in patients with HLA-DQ2.5+ coeliac disease.
“This study has informed the design of our planned Phase II clinical trial for Nexvax2 in patients with coeliac disease.
"Nexvax2 has the potential to protect against the effects of gluten exposure in patients with coeliac disease and improve their quality of life.”
The patients were given escalating doses of Nexvax2 or placebo followed by maintenance doses higher than those previously tested for a period of 46 or 60 days.
The results from earlier clinical trials showed that the first fixed dose administration of Nexvax2 causes transient immune activation and symptoms similar to gluten-ingestion, while later doses were well tolerated, with no immune response to the gluten epitopes.
Image: Biopsy of small bowel showing coeliac disease. Photo: courtesy of Samir / Wikipedia.